Sr. Medical Device QE

Our client is a Class II Medical Device company who is optimizing their manufacturing processes to create a universal reprocessing system that they can pick up drop it in other countries with different requirements. Once that is complete they will be begin the designing, building, testing and releasing of prototypes of their second-generation device.

Day-to-Day Responsibilities

The client is looking for a QE consultant with experience in manufacturing processes, reprocessing systems, process procedural writing, and design quality engineering. A background in ECG/data collection, A to D converters and DSPs is a plus. This consultant will initially be working on the manufacturing processes and then move into the design phase. They will be putting documentations in place, performing audits, enhancing processes, writing process procedures, and implementing the work instructions/work orders that will be laid out. Once the reprocessing phase is done, the consultant will be going through the design, building, testing, and releasing prototypes for this next generation device. This will include collecting and processing ECG data. This person will need to have the expertise to do this with little oversight from management. This person will be acting as a lead for this project.